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临床试验/NCT06578312
NCT06578312已完成不适用

A Study on Establishing a "Critical State" Early Warning Score After Congenital Heart Disease Surgery and an Integrated Treatment Model of a Multidisciplinary Rapid Response Team

Chinese Academy of Medical Sciences, Fuwai Hospital1 个研究点 分布在 1 个国家目标入组 4,115 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
4,115
试验地点
1
主要终点
event occurrence-an inclusion of composite clinical diagnose

研究概览

简要总结

By establishing a warning scoring tool for the early "critical state" after congenital heart disease surgery, the multidisciplinary rapid response team is proactively activated, forming an integrated treatment model of early warning-team decision-making-organ assistance.

详细描述

All children aged 0-14 years admitted to the PICU from 2021-2022 were enrolled continuously, and their baseline data such as gender, age, RACHS-1 score, cardiopulmonary bypass time, aortic clamping time, whether there was chromosomal lesions, whether there was preoperative endotracheal intubation/heart failure, changes in oxygenation index, lactate, and vasoactive drug scores were obtained. All variables that may lead to composite malignant events including death in the early postoperative period were included, including death, pulmonary hypertension crisis, malignant arrhythmias (supraventricular tachycardia, ventricular tachycardia, ventricular fibrillation, high-degree atrioventricular block) requiring antiarrhythmic drugs or pacemaker treatment, cardiopulmonary resuscitation, ECPR, emergency sternal expansion, severe AKI, severe ARDS, neurological complications (cerebral hemorrhage, cerebral infarction), gastrointestinal complications (gastrointestinal bleeding, intestinal obstruction, intestinal necrosis).The variables were included in the machine learning analysis to establish the model.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
28 Days 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • pediatrics admitted to ICU

排除标准

  • surgery without cardiopulmonary bypass
  • using extra-corporeal circulation during surgery
  • Delayed chest closing during surgery

结局指标

主要结局

event occurrence-an inclusion of composite clinical diagnose

时间窗: Within 48 hours after surgery

critical status included clinical diagnose:arrhythmia(ventricular tachycardia、ventricular fibrillation、refractory supraventricular tachycardia ),prognosis(death or live),bedside thoracotomy,CPR,ECMO,extracorporeal circulation establishment,renal replacement therapy,peritoneal dialysis, hemofiltration. If one of the above diagnosis and treatment used in patients, they would be divided to case group.

次要结局

未报告次要终点

研究者

发起方
Chinese Academy of Medical Sciences, Fuwai Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xu Wang

Chief Physician

Chinese Academy of Medical Sciences, Fuwai Hospital

研究点 (1)

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